Senior Manufacturing Associate II (Principal Biotechnologist) – Large Scale Allogeneic - Day Shift
Core
Senior technical leader responsible for upstream manufacturing operations, facility launch, and staff mentorship in a large-scale allogeneic cell therapy environment.
Role type
Senior Manufacturing Associate II (Principal Biotechnologist)
Builds
Large-scale allogeneic cell therapy products using single-use bioreactor technologies
Domain
Biopharmaceutical manufacturing / Cell therapy
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
cGMP compliance, upstream processing, aseptic techniques, cleanroom operations, electronic batch record management, staff training, change control, CAPA initiation
Preferred skills
Bioreactor inoculation, harvest, single-use systems, TrackWise platform
Technologies
Single-use bioreactor systems, TrackWise, EBR systems
Responsibilities
Lead upstream manufacturing operations including cell growth and product harvest; Execute aseptic setups in Grade B cleanrooms and monitor batches in Grade C; Support facility launch with engineering and water runs; Author and optimize cGMP documentation and SOPs; Train manufacturing staff on equipment and quality structures; Lead minor floor investigations and initiate change controls or CAPAs
Seniority
Senior, hands-on IC with leadership anchor responsibilities